The Effect of a Multispecies Probiotic on Hypersensitivity in Irritable Bowel Syndrome (IBS) Patients

This study has been completed.
Winclove Bio Industries BV
Information provided by (Responsible Party):
Maastricht University Medical Center Identifier:
First received: June 11, 2008
Last updated: January 28, 2013
Last verified: January 2013
The purpose of this study is to determine whether a specifically designed multispecies probiotic decreases visceral hypersensitivity in IBS-patient (defined by an increased pain tolerance threshold). Moreover, the effect on general symptom scores and inflammatory and microbiological parameters will be studied.

Condition Intervention
Irritable Bowel Syndrome
Dietary Supplement: multispecies probiotic (Ecologic 801)
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of a Multispecies Probiotic on Hypersensitivity in IBS Patients

Resource links provided by NLM:

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Pain tolerance threshold [ Time Frame: t=0 and t=6 weeks ] [ Designated as safety issue: No ]
  • VAS score for pain at pressure step 29 mmHg [ Time Frame: t=0 and t=6 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: August 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Dietary Supplement: multispecies probiotic (Ecologic 801)
once daily, 5 gram [10e9 cfu/gram]
Other Name: Ecologic 801
Placebo Comparator: 2 Dietary Supplement: Placebo
once daily, 5 gram [10e9 cfu/gram]


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of IBS according to the Rome III criteria
  • Increased visceral perception according to barostat measurements, defined as a pain tolerance threshold at smaller than or equal to 23 mmHg
  • Age between 18 and 65 years
  • BMI between 18.5 and 30 kg/m2

Exclusion Criteria:

  • Known gastro-intestinal diseases
  • Major abdominal surgery
  • Previous radiotherapy, chemotherapy
  • Clinical significant systemic diseases
  • Critically ill patients or patients suffering from severe acute pancreatitis
  • Patients with organs failure
  • Patients receiving enteral feeding
  • Excessive alcohol intake (greater than 15 consumptions per week)
  • (planned) pregnancy or lactation
  • Use of pre-, probiotics in the month before and during the study
  • Use of antibiotics in the two months before and during the study
  • Use of anti-diarrhoea medication, anti-laxatives or anti-acid medication in the two weeks before and during the study
  • Use of anti depressives (especially SSRI's) in the month before and during the study
  • Use of other medication if less then one month on stable dosage
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Please refer to this study by its identifier: NCT00702026

University Hospital Maastricht
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Winclove Bio Industries BV
Principal Investigator: A AM Masclee, Prof. Dr. Maastricht University Medical Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Maastricht University Medical Center Identifier: NCT00702026     History of Changes
Other Study ID Numbers: MEC 08-1-031 
Study First Received: June 11, 2008
Last Updated: January 28, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Irritable Bowel Syndrome

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Gastrointestinal Diseases
Immune System Diseases
Intestinal Diseases processed this record on May 25, 2016